(29 days)
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images. The Change Being Effected is the addition of a clarification instruction for the use of the introducer in the catheter device User Manual and Directions for Use.
This document describes the regulatory submission for the Siemens ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. The submission is for a modification to an already cleared device (K173618), specifically adding a clarification instruction in the user manual regarding the use of an introducer.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is for a labeling change to an already cleared device, and states that the device itself is unchanged, the "acceptance criteria" here refer to the demonstration of continued compliance with safety standards and the non-introduction of new safety or effectiveness concerns due to the labeling change. There are no new performance metrics reported for the device itself in this submission.
| Acceptance Criteria (Demonstrated) | Reported Device Performance (Compliance) |
|---|---|
| Device remains unchanged (technology, patient contact materials, principles). | Confirmed |
| Acoustic output verified. | Conforms to AIUM/NEMA UD-3, UD-2 |
| Biocompatibility verified. | Conforms to ISO 10993-1 |
| Cleaning and disinfection effectiveness verified. | (Implicitly maintained from predicate) |
| Thermal, electrical, electromagnetic, and mechanical safety verified. | Conforms to UL 60601-1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2 |
| Sterilization of health-care products verified. | Conforms to ISO 11135 |
| Packaging for terminally sterilized medical devices verified. | Conforms to ISO 11607-1 and ISO 11607-2 |
| The labeling change does not impact substantial equivalence of the catheter device. | Confirmed |
| The labeling change does not introduce new safety and effectiveness concerns. | Confirmed |
2. Sample size used for the test set and the data provenance
No new test set data was generated or used for this specific submission because the device itself is unchanged, and the submission is for a labeling modification. The substantial equivalence is based on the predicate device, K173618.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set data requiring expert review was generated for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set data requiring adjudication was generated for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasound catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ultrasound catheter, not an algorithm, and does not operate in a standalone algorithmic fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable to this submission, as it focuses on demonstrating continued safety and equivalence for a labeling change rather than new clinical performance data. The original predicate device's substantial equivalence would have been based on clinical experience and performance data typical for diagnostic intravascular catheters, but this detail is not provided in this document.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the (continued) acceptance criteria is primarily non-clinical testing and a comparative analysis against the predicate device (K173618).
- Rationale for the study: The submission states that "The catheter device remains unchanged from previously cleared submission for the predicate device, AcuNav Volume ICE Catheter (K173618). The Change Being Effected is the addition of a warning to clarify the proper use of the introducer used with the catheter device and does not introduce new safety and effectiveness concerns."
- Nature of the study: The "study" involves demonstrating that the modified device (with the labeling clarification) maintains substantial equivalence to the predicate device. This is achieved by:
- Verification of Unchanged Device Characteristics: Confirming that the device's technology, patient contact materials, and principles of operation are identical to the predicate.
- Compliance with Safety Standards: The document lists adherence to numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection (implicitly maintained), thermal, electrical, electromagnetic, and mechanical safety, as well as sterilization and packaging. These standards were presumably met by the predicate device and the unchanged hardware.
- Evaluation of the Labeling Change Impact: A critical aspect is the assessment that the addition of the clarification instruction in the user manual "does not impact the substantial equivalence of the catheter device as currently cleared under K173618" and "does not introduce new safety and effectiveness concerns." This is a regulatory determination based on reviewing the proposed labeling change.
- Conclusion: "Because the AcuNav Volume ICE catheter in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence." This statement directly indicates that the "study" for this submission focuses on non-clinical aspects and the lack of change in the device itself, making new clinical performance data unnecessary for proving continued acceptance.
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January 19, 2021
Siemens Medical Solutions USA, Inc. Hyunjung Lee Regulatory Technical Specialist 22010 S.E. 51st Street Issaquah, Washington 98029
Re: K203726
Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: December 17, 2020 Received: December 21, 2020
Dear Hyunjung Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203726
Device Name
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
Indications for Use (Describe)
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summarv
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c).
SPONSOR'S NAME & ADDRESS
Siemens Medical Solutions USA. Inc. 22010 S.E. 51st Street Issaquah, WA 98029, USA
OFFICIAL CORRESPONDENT
HyunJung Lee Regulatory Technical Specialist Phone: (425) 281-5061 Email: hyunjung.lee@siemens-healthineers.com
SUBMISSION DATE
December 17, 2020
TRADE NAME
ACUSON AcuNay Volume Intracardiac Echocardiography Catheter
COMMON NAME
Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE
Diagnostic Intravascular Catheter/ OBJ
CLASSIFICATION
Class II, 21 CFR 870.1200
PREDICATE DEVICE
#K173618, ACUSON AcuNav Volume ICE Catheter
DESCRIPTION OF MODIFIED DEVICE
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images. The Change Being Effected is the addition of a clarification instruction for the use of the introducer in the catheter device User Manual and Directions for Use.
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INDICATIONS FOR USE
The AcuNav Volume ICE catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
SUBSTANTIAL EQUIVALENCE CONCLUSION
The AcuNav Volume ICE catheter is substantially equivalent to the company's own previously cleared AcuNav Volume ICE catheter (K173618) with regard to both intended use and technological characteristics. The addition of the clarification in the product labeling does not impact the substantial equivalence of the catheter device as currently cleared under K173618. Both the subject catheter and the predicate catheter function in the same manner as all diagnostic ultrasound catheters.
| Feature / Characteristic | AcuNav Volume ICEThis Submission | AcuNav Volume ICEK173618 |
|---|---|---|
| Indications for Use: | ||
| ■ Cardiac | √ | √ |
| ■ Pediatric | √ | √ |
| ■ Intra-luminal | √ | √ |
| ■ Intra-cardiac | √ | √ |
| Patient Contact Materials | ISO 10993-1 | ISO 10993-1 |
A BRIEF DISCUSSION OF NONCLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON IN THE 510(K) FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE.
The catheter device remains unchanged and has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:
- · UL 60601-1, Safety Requirements for Medical Equipment
- · IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound ■
- Safety and EMC Requirements for Medical Equipment 트
- o EN/IEC 60601-1
- EN/IEC 60601-1-2 o
- . ISO 10993-1, Biocompatibility
- . ISO 11135, Sterilization of health-care products - Ethylene oxide
- . ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices
The cleared patient contact materials and mechanical safety are unchanged due to the change in labeling.
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A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE.
Because the AcuNay Volume ICE catheter in this submission uses the same technology. patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence.
SUMMARY
Intended use and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance.
The catheter device remains unchanged from previously cleared submission for the predicate device, AcuNav Volume ICE Catheter (K173618). The Change Being Effected is the addition of a warning to clarify the proper use of the introducer used with the catheter device and does not introduce new safety and effectiveness concerns.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).